Our client, a leading medical device company is looking for a Validation Quality Engineer for 6-month contract role in Galway.
- Planning and the execution of process validation activities for a technology transfer to the Galway site.
- Support the characterisation and risk assessment of manufacturing processes and associated equipment
- Work with project team members to establish process controls that ensure the safety and efficacy of the product.
- Liaise with cross functional team members, developing strong partnering relationships with these groups
Lead and support root cause driven approaches to problem solving efforts for quality issues.
- Use and establish analysis techniques and other quality tools to aid decision making
- Possess expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, validation, technology transfer and commercialization activities.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialise in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
- The Ideal Candidate:
Qualified to a Level 8 Third Level Degree in Science, Engineering or related discipline.
- Minimum of 2 years’ experience in relevant field.
- A dynamic team player and can work effectively and proactively on cross-functional teams.
- Experienced with the ability to be self-directed and to effectively interface with various levels and functions within the organisation.
- Broad technical expertise and knowledge of interrelated quality function disciplines and a high level of aptitude in QE/QA principles and methodologies is advantageous.
- A good working knowledge of process validation requirements and an ability to recognize, anticipate and innovatively create solutions to issues and problems in a timely manner is desirable.
For further information on this Engineer role in Galway please contact Orla on 0860449473/ email@example.com
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